Brain Organization, Development, and Response to Intervention in Individual Neonates
Overview
- Phase
- N/A
- Intervention
- Neonatal Massage
- Conditions
- Development, Infant
- Sponsor
- Washington University School of Medicine
- Enrollment
- 80
- Locations
- 4
- Primary Endpoint
- Change in correlated brain activity among functional brain areas in the somatomotor cortex
- Status
- Recruiting
- Last Updated
- yesterday
Overview
Brief Summary
The goal of this study is to learn about brain connectivity and if massaging babies shortly after birth has an impact. Half of the recruited babies will receive massage daily while the other half will not, and differences will be observed.
Investigators
Eligibility Criteria
Inclusion Criteria
- •English speaking
- •Ability to give informed consent
Exclusion Criteria
- •Prisoners (vulnerable population)
- •Pregnant women \<18 years of age
- •Active psychosis, mania, suicidal ideation (safety)
- •Active substance dependence
- •Gestational Age \<35 weeks (neonates)
- •Neonatal encephalopathy (neonates)
Arms & Interventions
Neonatal Massage Received
Intervention: Neonatal Massage
No Massage Received
Outcomes
Primary Outcomes
Change in correlated brain activity among functional brain areas in the somatomotor cortex
Time Frame: up to 3 months
Brain activity is measured across the brain with functional magnetic resonance imaging (fMRI) before and after the intervention. The timeseries of brain activity will be extracted from each of the subject-specific parcels of the somatomotor network (SMN). Parcels will be divided into those that represent the upper versus lower extremity. The average of the pairwise correlations in the timeseries between upper and lower extremity parcels is the "cross-effector SMN functional connectivity" that is the primary measure. This measure will be computed before and after the intervention; we predict a decrease in cross-effector SMN functional connectivity following the intervention.